View Clinical Trial (Medical Research Study)

A Randomized, Double-Blind, Phase 3b Study to Evaluate Effects of Aspirin or Slow Dose Titration on Flushing and Gastrointestinal Events Following Oral Administration of BG00012 Dosed at 240 mg BID

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Conditions:		Healthy Volunteers
Purpose:		The purpose of this study is to evaluate the effects of aspirin or slow dose titration on flushing and gastrointestinal events following the administration of oral BG00012.
Study Summary:		This is a study in healthy volunteers to evaluate if aspirin taken before BG00012 administration or slowly titrating BG00012 are able to reduce flushing and gastrointestinal events . This will provide information on how to improve BG00012 tolerability .
Criteria:		Inclusion Criteria: - Must give written informed consent and any authorizations required by local law - Must have a body mass index (BMI) of between 18.0 to 34.0 kg/m2,inclusive. - Ability to complete the tolerability scales by accurately using the hand-held subject reporting device - Subjects of childbearing potential must be willing to practice effective contraception Exclusion Criteria: - History of clinically significant diseases - History of severe allergic or anaphylactic reactions - Intolerance to Aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) - Diarrhea, constipation, abdominal pain, flushing or nausea within 28 days prior to Day 1
NCT ID:		NCT01568112
Primary Contact:		N/A
Backup Contact:		N/A
Location Contact:		St Paul, Minnesota United States There is no listed contact information for this specific location. Site Status: N/A

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